Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
Condition(s) studied
Study summary
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting.
ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. The main ROSSINI study will have approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain.
All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years.
Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires.
Eligibility
Primary outcome measure(s)
- Change From Baseline in OFF Time (hours) — Up to approximately 3 years
The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).
Trial sites (68)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 253477 | Birmingham | Alabama | |
| Banner Sun Health Research Institute /ID# 253461 | Sun City | Arizona | |
| Parkinson's Research Centers of America - Palo Alto /ID# 264703 | Palo Alto | California | |
| Georgetown University Hospital /ID# 259381 | Washington D.C. | District of Columbia | |
| Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 253465 | Boca Raton | Florida | |
| University of Florida College of Medicine /ID# 259383 | Gainesville | Florida | |
| University of Miami /ID# 259396 | Miami | Florida | |
| N1 Research, LLC /ID# 264221 | Orlando | Florida | |
| University of South Florida- Neuroscience Institute /ID# 253470 | Tampa | Florida | |
| Northwestern Medicine Primary And Specialty Care Lavin Family Pavilion /ID# 266977 | Chicago | Illinois | |
| Ochsner Medical Center - Jefferson Highway /ID# 269764 | New Orleans | Louisiana | |
| Boston Medical Center Health System /ID# 269765 | Brighton | Massachusetts | |
| University of Minnesota - Minneapolis /ID# 268121 | Minneapolis | Minnesota | |
| Kansas City VA Medical Center /ID# 253466 | Kansas City | Missouri | |
| Cleveland Clinic Lou Ruvo Cent /ID# 259390 | Las Vegas | Nevada | |
| David L. Kreitzman, MD, PC /ID# 259397 | Commack | New York | |
| Northwell Health /ID# 253469 | Lake Success | New York | |
| Novant Health Neurology and Sleep /ID# 259391 | Charlotte | North Carolina | |
| Atrium Health Wake Forest Baptist Medical Center /ID# 259387 | Winston-Salem | North Carolina | |
| NeuroCare Center /ID# 259392 | Canton | Ohio | |
| The Movement Disorder Clinic of Oklahoma /ID# 253463 | Tulsa | Oklahoma | |
| Vanderbilt University Medical Center /ID# 253474 | Nashville | Tennessee | |
| Texas Movement Disorder Specialists /ID# 253473 | Georgetown | Texas | |
| Univ Texas HSC San Antonio /ID# 259394 | San Antonio | Texas | |
| University of Utah /ID# 253471 | Salt Lake City | Utah | |
| Evergreenhealth Medical Center /ID# 268120 | Kirkland | Washington | |
| Inland Northwest Research /ID# 253460 | Spokane | Washington | |
| Westmead Hospital /ID# 259670 | Westmead | New South Wales | |
| The Royal Melbourne Hospital /ID# 259671 | Parkville | Victoria | |
| Klinik Ottakring /ID# 262773 | Vienna | State of Vienna | |
| Medizinische Universitaet Graz /ID# 262774 | Graz | Styria | |
| Medizinische Universitaet Innsbruck /ID# 262775 | Innsbruck | Tyrol | |
| Kepler Universitaetsklinikum GmbH /ID# 262776 | Linz | Upper Austria | |
| University of Calgary /ID# 262833 | Calgary | Alberta | |
| The Ottawa Hospital - General Campus /ID# 263315 | Ottawa | Ontario | |
| CHUM - Centre hospitalier de l'Universite de Montréal /ID# 269689 | Montreal | Quebec | |
| Centre de Recherche St-Louis /ID# 262746 | Québec | Quebec | |
| Bispebjerg Hospital /ID# 252032 | Copenhagen | Capital Region | |
| Rigshospitalet Glostrup /ID# 252035 | Glostrup Municipality | Capital Region | |
| Odense University Hospital /ID# 252036 | Odense | Region Syddanmark |
+ 28 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06107426 on ClinicalTrials.gov ↗ ← All trials in the USA